🇨🇱 Bioavailability & Bioequivalence (BA/BE) Studies Services for Chile
ISP–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with Chile’s pharmaceutical regulatory framework under:
ISP – Instituto de Salud Pública de Chile
Ministerio de Salud (MINSAL)
All studies strictly follow ISP regulations, ICH guidelines, WHO TRS, GCP, and GLP, ensuring compliance for Chilean regulatory submissions and broader Latin American market approvals.
💊 Core Services for Chile (ISP / MINSAL) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose crossover or parallel BE study designs approved by ISP.
• Volunteer Selection: Healthy volunteers or relevant patient groups depending on therapeutic category.
• Ethics Approval: Required approval from a Comité Ético Científico (CEC) accredited in Chile.
• Protocol Development: Prepared in accordance with ICH E6 (R2) GCP, WHO TRS, and ISP’s technical guidelines for BE studies.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for pharmaceutical equivalence, generics, formulation changes, and ISP drug registration.
• Dissolution Media: Pharmacopeial and biorelevant media accepted by ISP.
• Similarity Factor: f2 similarity factor for dissolution comparison.
• Evaluation Methods: WHO/ICH-recognized model-independent (f1, f2) and model-dependent approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and ISP biowaiver criteria (when applicable).
• IVIVC Modeling: Level A, B, and C models for in vitro–in vivo correlation.
• Predictive PK Modeling: Supports regulatory justification for biowaiver and BE strategy optimization.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems.
• Validation: Conducted per ICH M10, WHO TRS, and ISP’s analytical validation requirements.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Executed using WHO/ICH harmonized statistical methodologies.
• Sample Size & Power: Scientifically calculated to meet ISP confidence standards.
📑 Chile ISP–Ready Regulatory Documentation
We prepare comprehensive Chile-specific regulatory documentation, including:
• Clinical Study Protocol (Chile/ISP-compliant)
• Informed Consent Forms (ICF) per CEC ethical norms
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) structured for ISP submission
✨ Why Choose BioEquiGlobal for the Chilean Market?
• In-Depth Regulatory Expertise: BE protocols, dissolution studies, analytical validation, and CTD dossiers tailored to ISP requirements.
• International Quality Compliance: GCP, GLP, WHO TRS, and ICH standards enforced through robust QA systems.
• Advanced Clinical & Analytical Facilities: Accredited clinical units and modern analytical laboratories (including NABL-certified labs).
• Global Dossier Support: CTD preparation for Chile and major global authorities (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Chile
Feasibility & Gap Assessment: Reference product feasibility, dissolution assessment, and biowaiver eligibility.
Protocol Development: Drafting ISP-compliant BA/BE protocols and securing ethics approval from a CEC.
Analytical Method Development: LC-MS/MS method development & validation per ICH M10 & WHO TRS.
Clinical Study Execution: GCP-monitored recruitment, dosing, blood sampling, and medical oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical analysis.
Documentation & Submission: Preparation of ISP-ready CSR, dissolution reports, validation documentation, and CTD/ACTD modules.
Who We Support
• Pharmaceutical companies targeting Chile and the Latin American region
• CROs needing BA/BE outsourcing or analytical services
• Regulatory teams seeking ISP-compliant CTD/ACTD dossiers